JELFA SA DISTRIBUTES FINAL PRODUCT WITH QUESTIONABLE STERILITY 1.  Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192]. For example, The inspection documented that (b)(4) … [Read more...]
ALLURE LABS RECEIVES WARNING LETTER (5/24/11)
ALLURE LABS’ CITED FOR FAILURE TO CALCULATE MICROBIOLOGICAL DILUTION FACTOR CORRECTLY WITHIN PRODUCT LEADS TO PRODUCT FAILURE We have reviewed your firm’s response dated December 12, 2010, and note that it lacks sufficient corrective actions. We acknowledge your second written response, dated February 3, 2011, to the Form FDA 483. However, because this response was received … [Read more...]
Indian Mexican API Facilities Cited by FDA in Warning Letter
Dr. Reddy's Laboratories Found in Non-Compliance and In Receipt of an Import Ban Comment Dr Reddy's Mexico facilities were inspected between November 8-11, 2010. During the audit the FDA identified significant deviations from CGMP for the manufacture of APIs. These deviations caused the APIs to be adulterated. A response dated December 1, 2010, received by the Agency, … [Read more...]
FDA ISSUES WARNING LETTER FOR CLINICAL SUPPLY MANUFACTURING FACILITIES — FEBRUARY 10, 2011
Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
FDA ISSUES — MEDIA GROWTH PROMOTION STUDIES McNEIL-PPC, DELTEX PHARMA, RIBBON PHARMA & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER
FDA ISSUES -- MEDIA GROWTH Â PROMOTION STUDIES McNEIL-PPC, DELTEXÂ PHARMA, RIBBON PHARMAÂ & CHEMICAL, COLUMBIA PRESBYTERIAN MEDICAL CENTER Comment Comments Regarding Proposed Changes to USP General Chapter <823> Radiopharmaceuticals for Positron Emission Tomography-Compounding were recently made to the USP as they move forward in … [Read more...]
